![Drug Classifications
1. Therapeutic Use/ Clinical Indications
Examples:
Antibiotics
○ cefuroxime, penicillin, erythromycin
Laxatives
○ Bulk-forming
Sterculia [Normacol], methylcellulose (Citrucel)
○ Stool softeners
(Colace, Diocto)
○ Lubricants or emollient
Diuretics
Antacids
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![Drug Name
Chemical Name:
0-[(2S)-3-mercapto-2-
methylpropionyl]-L-
proline[MW217.29]
Generic Name:
captopril
Trade Name:
Capoten
Official Name:
captopril
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Uploaded byLudy Mae Nalzaro,BSM,BSN,MN
PHARMA-DRUG EVALUATION
The document discusses drug evaluation and approval processes. It describes how drugs are classified as either therapeutic or non-therapeutic and must be approved by regulatory agencies like the FDA. The drug approval process involves four stages of clinical trials before a new drug application is submitted for review. Drugs are also classified based on their intended use, mechanism of action, prescription status, and legality. Federal legislation like the Food, Drug and Cosmetic Act and its amendments aim to ensure drug safety and effectiveness.
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PHARMA-DRUG EVALUATION
- 1.
- 2. DRUG EVALUATION Process of classifying drugs as either therapeutic or non-therapeutic and are approved by a governing agency 2
- 3. DRUG APPROVAL PROCESS 1.Food and Drug Administration (FDA) - US Agency in-charge of monitoring the use of drugs as well as its development. 2. Bureau of Food and Drug Administration (BFAD) – Philippines Concerns of these agencies are 2-fold: Whether the drugs are effective Whether the drug is safe for human use 3
- 4. Drugs for approvalshould pass through 4 Stages of New Drug Development. 4
- 5. Stages of NewDrug Development 1. Preclinical Study 2. Clinical Study 1. Phase I 2. Phase II 3. Phase III 3. New Drug Application (NDA) review 4. Post Clinical Study 5
- 6. Stages of NewDrug Development 1. Preclinical Study Starts with the discovery, synthesis and purification of drug Functions: To know if with therapeutic value Safe in animals 6
- 7. Stages of NewDrug Development 2. Clinical Study “testing in humans” stage. 3 phases: Phase I ○ Tested in small # of healthy volunteers. ○ Initial info on the effects in humans Phase II ○ Tested in small, selected population (10-150 subjects) ○ To evaluate the therapeutic effect in treating specific disease/pathologic condition. Phase III ○ More cients (several hundredths-thousands) ○ Provides info on proper dosing and safety. 7
- 8. Stages of NewDrug Development 3. New Drug Application (NDA) Review the drug is submitted to FDA for new drug application. 8
- 9. Stages of NewDrug Development 4. Post Clinical Study Known as “postmarketing surveilance” Final stage of drug approval process It surveys the drug’s harmful effects. 9
- 10.
- 11. Drug Classifications 1. Therapeutic Use/Clinical Indications 2. Physiologic/Chemical Action 3. Prescribed (Ethical) Drug 4. Non-prescription (Non-Ethical) Drugs 5. Illegal Drugs 11
- 12. Drug Classifications 1. Therapeutic Use/ Clinical Indications Examples: Antibiotics ○ cefuroxime, penicillin, erythromycin Laxatives ○ Bulk-forming Sterculia [Normacol], methylcellulose (Citrucel) ○ Stool softeners (Colace, Diocto) ○ Lubricants or emollient Diuretics Antacids 12
- 13. Drug Classifications 2. Physiologic/Chemical Action Examples: 1. Beta-adrenergic blockers ○ management of cardiac arrhythmias ○ block the action of epinephrine and norepinephrine ○ Ex. propanolol 13
- 14. Drug Classifications 2. Physiologic/Chemical Action Examples: 2. Anticholinergics ○ inhibit parasympathetic nerve impulses responsible for the involuntary movements of smooth (GI, urinary, etc) ○ Ex. Atropine sulfate 14
- 15. Drug Classifications 2. Physiologic/Chemical Action Examples: 3.Cholinergics ○ drug that functions to enhance the effects mediated by acetylcholine 4. Calcium channel blockers ○ to decrease blood pressure ○ Antiepileptics ○ Ex. Dihydropyridine 15
- 16. Drug Classifications 3. Prescribed(Ethical) Drug Requiring prescriptions Ordered/dispensed only by an authorize practitioner 16
- 17. Drug Classifications 4. Non-prescription(Non-Ethical) Drugs Drugs available over the counter Not requiring any prescription for use Can be purchased directly by consumer Used to treat relatively minor problems and conditions Judged to be safe for used by the consumer without direct medical supervision 17
- 18. Drug Classifications 5. IllegalDrugs Use for non-therapeutic purposes. Also referred as “recreational drugs” Drugs not approved by FDA/BFAD 18
- 19.
- 20. #10 SOLVENT 20
- 21. #9 PsychedelicMushrooms (hallucinogenic mushrooms ) 21
- 22. #8 Opium (addictive painkiller ) 22
- 23. #7 LSD (Lysergic Acid Diethylamide) most powerful hallucinogenic 23
- 24. #6 Barbiturates / Benzodiazepines (a prescription medicine) 24
- 25. #5 Amphetamines affecting the amount of dopamine and serotonin in the brain 25
- 26. #4 Ecstasy Psycho therapeutic drug produces euphoria and a feeling of well being, decreased levels of fear and anxiety and a physical stimulant and sensational effect in users. 26
- 27. #3 Cocaine (Coca plan) powerful stimulant, appetite suppressant and anesthetic 27
- 28. #2 Heroin/Diamorphine powerful painkiller and users experience exhilaration, euphoria and a sense of well being. 28
- 29. #1 Cannabis or Marijuana,Grass, Hemp, Weed, Pot, Hash, Dope slightly drunken but euphoric sensation 29
- 30.
- 31. Drug Standards andLegislation Drug Standards The United Pharmacopoeia National Formulary (USP NF) ○ the current authoritative source for drug standards (revised every 5 years by a group of experts in nursing: pharmaceutics, pharmacology, chemistry, and microbiology) ○ Drugs included in the USP-NF have the standards for: therapeutic use client safety quality purity strength packaging dosage form 31
- 32. Drug Standards International Pharmacopoeia – first published in 1951 by WHO ○ provides basis for standards in strength and composition of drugs worldwide ○ published in English, Spanish, and French (revised every 5 years) 32
- 33. FEDERAL LEGISLATION Purpose – to ensure safety (drugs that are impure, toxic, ineffective, or not tested before public sale) do not include drug effectiveness and drug safety 1938: Food, Drug, and Cosmetic Act empowered a governing body—the Food and Drug Administration (FDA) and Cosmetic Act of 1938 Purpose: to monitor and regulate the manufacture and marketing of drugs FDA’s responsibility is to ensure that all drugs are tested for harmful effects, have labels with accurate information, drug literature that explains adverse effects 33
- 34. FEDERAL LEGISLATION 1952: Durham-Humphrey Amendment amendment to the FDA and Cosmetic Act of 1938 distinguished between drugs that be sold with or without prescription and those that should not be refilled without a new prescription (ex. Narcotics, hypnotics, or tranquilizers; must be labeled) It also specified that all other drugs are approved for use to be considered non-prescription drugs 34
- 35. 1962: Kefauver-Harris Amendment tightened controls on drug safety, especially experimental drugs, and required that adverse reactions and contraindications must be labeled and included in the literature it added requirements that both prescription and non-prescription drugs be shown to be effective as well as safe thalidomide tragedy1950 – pregnant European women who took the sedative-hypnotic thalidomide during their first trimester of pregnancy gave birth to infants with extreme limb deformities. 35
- 36. A German pharmaceuticalcompany, Chemie Grünenthal at Stolberg,synthesized thalidomide in West Germany in 1953. It had accidentally been discovered during a search for cheap antibiotics, but was soon marketed with little evidence as a sedative. In 1961 the drug was found to be harmful to the unborn children of pregnant women 36
- 37. 1978: Drug RegulationReform Act This reform act shortened the time in which new drugs could be developed and marketed. 1992: Drug Relations Act The regulations were changed to increase the approval rates of drugs used to treat AIDS and cancer The pharmaceuticals pay a users fee at the time they file the application for the new drugs (for FDA approval process). 37
- 38. 1997: The Foodand Drug Administration Modernization Act 5 Provisions included in this act: Review and use of new drugs is accelerated. Drugs can be tested in children before marketing. Clinical trial data is necessary for experimental drug for serious or life- threatening health conditions. Drug companies are required to give information on “off-label” drugs (non- FDA approved drugs) and their uses and costs Drug companies that plan to discontinue drug must inform health professionals and clients at least 6 months before stopping drug production 38
- 39. LEGAL REGULATIONS OFDRUGS 1. Pregnancy Categories Reviews drug labeling information on pregnancy and risk effects to the fetus 39
- 40. Drug Pregnancy Categories CATEGORY A: No risk to fetus. Studies have not shown evidence for fetal harm. CATEGORY B: No risk in animal studies, and well-controlled studies in pregnant women are not available. It is assumed there is little to no risk in pregnant women. CATEGORY C: Animal studies indicate a risk to the fetus. Controlled studies on pregnant women are not available. Risk versus benefit of the drug must be determined. CATEGORY D: A risk to the human fetus has been proven. Risk versus benefit of the drug must be determined. It could be used in life-threatening conditions. CATEGORY X: A risk to the human fetus has been proven. Risk outweighs the benefits and drug should be avoided during pregnancy. 40
- 41. LEGAL REGULATIONS OFDRUGS 2. Controlled Substances Comprehensive Drug Abuse Prevention and Control Act of 1970 known as “Controlled Substance Act” ○ To improve the administration and regulation of manufacturing, distribution, and dispensing of drugs found necessary to be controlled ○ Consist of 5 classifications or schedules of controlled substance ○ The degree of control, the condition of record keeping, and the particular order form required, and other regulation depends on these classifications. 41
- 42. LEGAL REGULATIONS OFDRUGS 2. Controlled Substances Drug Enforcement Administration (DEA) Organize to enforce the Controlled Substance Act To gather intelligence, train and conduct research in the area of dangerous drug and drug abuse 42
- 43. LEGAL REGULATIONS OFDRUGS 3. Generic Drugs Drug which is produced and distributed without patent protection. Drugs which may still have a patent on the formulation but not on the active ingredient It must contain the same active ingredients as the original formulation Identical/bioequivalent to the brand name counterpart since these drugs should be identical in dose, strength, route of administration, safety, efficacy and intended use. 43
- 44. LEGAL REGULATIONS OFDRUGS 4. Orphan Drugs Drugs that have been discovered but not financially viable and therefore have not been “adopted” by any drug company. 44
- 45. Drug Nomenclature Chemical Name describes the drug’s chemical structure Chemical constitution of the drug & the exact placing of its atoms or molecular groupings. Generic Name (nonpropriety names) Common name or non-proprietary name for the drug ○ this name is not owned by any pharmaceutical (drug) company and is universally accepted Brand Name or Trade Name (proprietary name) ○ also chosen by the drug company and is usually a registered trademark owned by that specific manufacturer ○ Uses the symbol ® 45
- 46. Drug Name Chemical Name: 0-[(2S)-3-mercapto-2- methylpropionyl]-L- proline[MW217.29] Generic Name: captopril Trade Name: Capoten Official Name: captopril 46
- 47. Drug Uses 1. Symptomatic treatment. ANTI-EMETIC DRUGS 2. Preventive drug helps the body avoid disease. VACCINES & TOXOIDS 3. Diagnostic drugs help the physician determine whether a disease is present 4. Curative drugs eliminate the disease. ANTICANCER AGENT & ANTIBIOTICS 5. Health maintenance drugs help the body to function normally. VITAMINS & MINERALS 6. Contraceptive drugs prevent pregnancy. ORAL CONTRACEPTIVES/SPERMICIDAL AGENTS 47
- 48. Properties of IdealDrug 1. Effectiveness: A drug that elicits the response it was meant to. It is the most important property. No effect=no justification of use (FDA approved with appropriate experiments). 48
- 49. Properties of IdealDrug 2. Safety: Pharmakon = poison in Greek Safe even at high concentrations and for long periods of administration (no such thing as a safe drug) ○ Reduced by proper administration (iv, im, sc, etc…) ○ No habit forming aspects ○ No side effects ( excessive dosage of opoid analgesics carries a risk of respiratory failure, cancer drugs increase infections, aspirin causes gastric ulcer etc…) 49
- 50. Properties of IdealDrug 3. Selectivity: One that elicits only the response for which it is given Selective for specific reaction with no side effects (there is no such thing) ○ Drowsiness can be caused by antihistamines ○ Morning sickness, cramps, and depression can be caused by oral contraceptives ○ Constipation, urinary hesitance, and respiratory depression can be caused by morphine 50
- 51. Additional Properties ofIdeal Drug (no drug is ideal!) 1. Reversible action Effects be reversible, i.e., removal/subside w/i specific time (1/2 life is short but potent during that time) Example: General Anesthetic; Contraceptives 51
- 52. Additional Properties ofIdeal Drug (no drug is ideal!) 2. Predictability Know how patient will respond 3. Ease of Administration Number of doses should be low and easy to administer increase compliance & decrease errors ○ Diabetic patient: Multiple daily injection of insulin ○ Intravenous infusion 52
- 53. Additional Properties ofIdeal Drug (Continued) 4. Freedom from drug interactions Should not augment or decrease action of other drugs or have adverse combined effects ○ Respiratory depression caused by diazepam (Valium), which is normally minimal, can greatly be intensified by alcohol. ○ Antibacterial effects of Tetracycline can be greatly reduced by taking iron or calcium supplements 53
- 54. Additional Properties ofIdeal Drug (Continued) 5. Low Cost Easy to afford (especially with chronic illness) ○ Growth hormone (somatrem) costs between $10,000 and $20,000 ○ Lifelong medication: hypertension, arthritis, diabetes 54
- 55. Additional Properties ofIdeal Drug (Continued) 6. Chemical Stability No lose of effectiveness with storage 7. Possession of a simple generic name Easy to remember and pronounce ○ Example: Viagra (sildenafil); Tylenol (acetaminophen) 55
- 56. Because No Drugis Ideal…….. Because no drug is ideal……. No medications are ideal No drug is safe All drugs produce side effects Drug responses may be difficult to predict Drugs may be expensive Drugs may be hard to administer All members of health care team must exercise care to promote therapeutic effects and minimize drug induced harm 56
- 57. Therapeutic Objective To provide maximum benefit with minimum harm Factors that determine Intensity of Response Administration- dosage size and route Pharmacokinetic processes Pharmacodynamics Individual Variations 57
- 58. Therapeutic Objective 1. Administration-dosage size and route - Because of errors in administration routes and dosage and at wrong time there are many discrepancies in what patient gets and could cause more harm than good - Errors could be made by pharmacists, physicians, or nurses - Should give patients complete instruction about their medication and how to take it 58
- 59. Therapeutic Objective 2. Pharmacokineticprocesses - Determines how much of an administered dose gets to its sites of action ○ 1) drug absorption ○ 2) drug distribution ○ 3) drug metabolism ○ 4) drug excretion 59
- 60.
- 61. Therapeutic Objective (continued) 3. Pharmacodynamics pharmacodynamic processes determine the type of response and intensity Once a drug has reached its site of action, it must first bind to its specific target site at (RECEPTOR) Receptor may be a chemical, a protein on a cell or in blood or tissue spaces, or on a bacteria or virus Ex. heparin, antibody, leukotriene receptor (new), penicillin, etc 61
- 62. Therapeutic Objective (continued) 3. Pharmacodynamics Series of events that result in response such as inhibition of: 1. Clotting 2. Peptidoglycan synthesis 3. Inflammation 4. Blocking of virus 62
- 63. Therapeutic Objective (continued) 4. Sources of individual variation Each patient is unique in ability to respond and to how they each respond, but formation of “IDEAL DRUG” will lessen this variation ○ Age- very important factor ○ Sex- due to hormonal differences ○ Weight less effective and longer lasting in obese individuals (storage in fat) ○ Kidney & liver functions - elimination of drug ○ Genetic variables- tolerance, allergy (though not always genetic) 63
- 64. Factors that determinethe intensity of drug response 64
- 65. Summary To promote desired effects and minimize adverse effects, we need to understand Pharmakokinetics Pharmacodynamics In addition ○ Sources of individual variation in drug response 65
- 66. Key Points The most important properties of an ideal drug are: effectiveness, safety, and selectivity. If the drug is not effective, it should not be used. There is no such drug as safe drug: all drugs can cause harm. There is no such thing as selective drug: all drugs can cause side effects. The objective of drug therapy is to provide maximum benefit within minimum harm. Because all patients are unique, drug therapy must be tailored to each individual. 66
- 67. ASSIGNMENT GIVE 5 EXISTING LAWS (INTERNATIONAL & LOCAL) REGARDING FOOD AND DRUG REGULATION/ADMINISTRATION. THEN, MAKE A REACTION (AT LEAST 200 WORDS). 67
- 68. ASSIGNMENT RA 9165 THE COMPREHENSIVE DANGEROUS DRUGS ACT OF 2002 FURNISH A COPY OF THE LAW ANSWER THE FOLLOWING QUESTIONS: 1. WHAT IS THE IMPORTANCE OF SUCH LAW AS A NURSING STUDENT AND AS A CITIZEN OF THE COUNTRY? 2. HOW CAN YOU CONTRIBUTE TO THE IMPLEMENTATION OF THE LAW AS A HEALTH CARE PROVIDER? CITE EXAMPLES IN THE COMMUNITY AND HOSPITAL SETTING 3. HOW CAN YOU APPLY THIS REPUBLIC ACT TO YOUR SELF AS A CITIZEN? 68